You are here

A Study to Evaluate The Pharmacokinetics Of Crizotinib (PF-02341066) In Subjects With Impaired Renal Function

Last updated on February 20, 2019

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Anaheim, California, 92801 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Renal Impairment
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

All Subjects

- Healthy male and/or female of non childbearing potential subjects between the ages of
18 and 65 years, inclusive ('healthy' is defined as no clinically relevant
abnormalities identified by a detailed medical history, full physical examination,
including blood pressure and pulse rate measurement, 12 lead ECG, and clinical
laboratory tests).

- Body Mass Index (BMI) of 18 to 40 kg/m2 inclusive; and a total body weight >50 kg
(>110 lbs).

Subjects with Normal Renal Function (Group 1)

- Normal renal function (CLcr =>90 mL/min) during the screening period.

- Matched 1-to-1 to subjects in Group 2 with respect to age (+/-5 years), weight (+/-10
kg), gender, and race according to protocol.

Subjects with Severe Renal Impairment (Groups 2)

- Good general health commensurate with the population with chronic kidney disease.

- Severe renal impairment (CLcr

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

All Subjects

- Renal allograft recipients.

- Any condition possibly affecting drug absorption.

- 12 lead ECG demonstrating QTc >470 msec at screening.

- Urinary incontinence without catheterization.

- A positive urine drug screen.

- History of regular alcohol consumption.

- Treatment with an investigational drug within 30 days (or as determined by the local
requirement, whichever is longer) or 5 half lives preceding the first dose of study
medication.

- Pregnant or nursing females; females of childbearing potential, including those with
tubal ligation.

- Blood donation of approximately 1 pint (500 mL) within 56 days prior to dosing.

Subjects with Severe Renal Impairment (Groups 2)

- Subjects with any significant hepatic, cardiac or pulmonary disease (apart from stable
ischemic heart disease), or subjects who are clinically nephrotic.

- Subjects requiring hemodialysis.

- Subjects with strict fluid restriction (ie,

- Significant bleeding diathesis which could preclude multiple venipuncture.

- Use of food or drugs that are CYP3A4 inhibitors and inducers.

- Herbal supplements and hormone replacement therapy must be discontinued 28 days prior
to the first dose of trial medication

- Concurrent use of drugs that are CYP3A4 substrates with narrow therapeutic indices.

NCT01419041
Pfizer
Completed
A Study to Evaluate The Pharmacokinetics Of Crizotinib (PF-02341066) In Subjects With Impaired Renal Function

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

call now

Try a new search

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

Renal Impairment
NCT03542305
All Genders
18+
Years
Multiple Sites
Renal Impairment
NCT01740362
All Genders
18+
Years
Multiple Sites

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

Call Now